Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT03664921|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathies Neuropathic Pain Pain, Chronic||Drug: Omnitram Oral Tablet Drug: Placebo Oral Tablet||Phase 2|
A multi-centered, randomized, double-blind, placebo-controlled, two-period cross-over study to compare the safety and efficacy of Omnitram (30 mg to 120 mg daily) and placebo in patients with painful diabetic polyneuropathy. For subjects receiving treatment for neuropathic pain prior to study enrollment, their treatment will be tapered and stopped at least 2 weeks before they will be enrolled. Approximately fifty subjects will be randomized in a double-blind manner to a 4-week treatment period of Omnitram or placebo. After a washout of at least one week, patients will cross-over to the other treatment for a second 4 week treatment period with Omnitram or placebo.
During the first two weeks of each treatment period, guided by efficacy and tolerability, the dose will be increased from 3 tablets to 12 tablets per day given in three equal doses at approximately at 8 am, 2 pm and 8 pm (i.e., if the tablet is Omnitram, 30, 60, 90 or 120 mg/day). During the final two weeks of the treatment period, the doses will be kept constant at the highest tolerated titrated dose. Up to six tablets daily of 500 mg oral acetaminophen can be used as rescue medication except on the last 4 days of each treatment segment (Days 26, 27, 28, and 29).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Investigating the Safety and Efficacy of Omnitram in Diabetic Neuropathy|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Oral Omnitram (10 mg tablets) dosed three times daily. During the first two weeks each dose will be titrated between 1 tablet (10 mg) and 4 tablets (40 mg) to provide pain relief. The doses administered at the end of two weeks will be maintained during the final two weeks of treatment.
Drug: Omnitram Oral Tablet
Administered three times daily for 28 consecutive days.
Placebo Comparator: Placebo
Oral placebo (tablets) dosed three times daily. During the first two weeks each dose will be titrated between 1 tablet and 4 tablets to provide pain relief. The doses administered at the end of two weeks will be maintained during the final two weeks of treatment.
Drug: Placebo Oral Tablet
Administered three times daily for 28 consecutive days.
- Numeric Pain Scale [ Time Frame: up to 28 days of each treatment. ]Subjects rate their pain intensity on a scale from 0 = no pain to 10 = worst possible pain
- Neuropathic Pain Symptom Inventory [ Time Frame: The questionnaire is completed at Day 1 and Day 29 of both treatments. ]Subjects complete the questionnaire.
- Sleep Problem Scale [ Time Frame: The questionnaire is completed at Day 1 and Day 29 of both treatments. ]Subjects complete the questionnaire.
- Major Depression Inventory [ Time Frame: The questionnaire is completed at Day 1 and Day 29 of both treatments. ]Subjects complete the questionnaire.
- Global Assessment of Treatment [ Time Frame: The assessment is completed on Day 29 of both treatments. ]Independently the subject and Investigator assess the treatment on a 5-point scale (excellent, very good, good, fair, poor).
- Global Impression of Change [ Time Frame: The assessment is completed on Day 29 of both treatments. ]The subject assesses overall change on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
- Average Daily Use of Acetaminophen [ Time Frame: Day 1 through Day 25 of both treatments. ]Subjects may use a maximum of 3 grams of acetaminophen each day.
- Adverse Events [ Time Frame: Subjects report adverse events throughout study enrollment; investigators observe adverse events during subject clinic visits on Day 7 and Day 29 of each treatment, and at the final safety visit 2 weeks after the completing both treatments. ]Adverse events include: 1) reports by subjects; and 2) observations by investigators.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664921
|Contact: Stuart Kahn, MDfirstname.lastname@example.org|
|United States, Missouri|
|St. Louis Clinical Trials||Recruiting|
|Saint Louis, Missouri, United States, 63141|
|Contact: Erica Ridolfi, CCRC 314-802-8822 email@example.com|
|Principal Investigator: Shenif Ladak, M.D.|
|United States, Texas|
|Endeavor Clinical Trials, LLC||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Lisa A. Rodriguez 210-949-0807 firstname.lastname@example.org|
|Principal Investigator: Richard Pollak, D.P.M., M.S.|
|Study Director:||Stuart Kahn, MD||Syntrix Biosystems|